Healthcare Industry News:  Diabetic Foot Ulcer 

Devices Surgery Wound Care FDA

 News Release - January 22, 2009

ConvaTec Announces Expanded Indications for AQUACEL(R) and AQUACEL(R) Ag Dressings in Management of Surgical Wounds

Represents Latest Advancement for ConvaTec Proprietary Hydrofiber® Technology

SKILLMAN, N.J., Jan. 22 -- (Healthcare Sales & Marketing Network) -- ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today that the company received expanded indications from the U.S. Food and Drug Administration (FDA) for its AQUACEL® and AQUACEL® Ag Dressings with Hydrofiber® Technology for the management of surgical wounds that heal by primary intent, building upon the products' extensive indications for chronic and acute wounds.

AQUACEL® and AQUACEL® Ag Dressings are soft, absorbent barrier wound dressings which feature the unique gelling benefits of ConvaTec Hydrofiber® Technology. AQUACEL® Ag Dressing also provides the broad-spectrum antimicrobial properties of ionic silver, which kills a broad range of pathogens in the dressing, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).(1)

"Approximately 27 million surgical procedures are performed annually in the United States.(2) ConvaTec is extremely pleased that, with this expanded indication, health care professionals will now be able to safely and effectively use both AQUACEL® and AQUACEL® Ag Dressings across a broad spectrum of wounds related to surgical incisions," said Marcus Schabacker, Chief Scientific Officer.

In addition to the new indication for the management of surgical wounds that heal by primary intent (including dermatologic, orthopedic and vascular incisions), the initial indication for use in surgical wounds left to heal by secondary intent was clarified to specifically encompass dehisced surgical incisions. AQUACEL® Ag Dressing also received an expanded indication for the management of infected wounds.

"The expanded indication for use in orthopedic wounds is particularly significant," added Schabacker. Blistering, often associated with orthopedic dressings, can lead to infection, delay healing and increase hospital length of stay.(3) "AQUACEL® and AQUACEL® Ag Dressings provide an effective alternative for the management of orthopedic surgical wounds."

These latest indications for AQUACEL® and AQUACEL® Ag Dressings follow the expanded indication each received from the FDA in 2007 for the management of painful wounds. The unique gelling action of Hydrofiber® Technology has been shown to reduce wound pain while the dressing is in situ and help reduce the pain and trauma upon dressing removal.(4) Hydrofiber® Technology is also featured in the company's recently launched Versiva® XC(TM) Gelling Foam Dressings.

These dressings gel on contact with wound fluid, which is locked inside the dressing to protect the periwound skin, while maintaining a moist environment to support healing and protect newly formed tissue from damage on removal.

According to a study published last year in the Journal of the American Medical Association, the estimated number of patients in the United States developing invasive MRSA infections in 2005 was 94,360.(5) Approximately 85 percent of those infections were associated with health care delivery,(5) and approximately 14 percent of those infections occurred in persons without obvious exposures to health care settings.(5)

According to the Centers for Disease Control and Prevention, surgical site infections are the third most frequently reported hospital-acquired infections, accounting for 14 to 16 percent of all nosocomial infections among hospitalized patients.(2)

AQUACEL® and AQUACEL® Ag Dressings have been studied in numerous randomized clinical trials across a variety of chronic and acute wounds, including pressure ulcers, leg ulcers, Diabetic Foot Ulcers, partial thickness (second degree) burns and surgical incisions.

About ConvaTec

ConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key business divisions -- Ostomy Care, Wound Therapeutics, Continence and Critical Care and Infusion Devices -- ConvaTec products support health care professionals from the hospital to the community health setting. From its headquarters in Skillman, New Jersey, the company oversees more than 8,000 employees in over 90 countries serving consumers and their health care professionals on six continents. For more information, please visit www.convatec.com.

References

1. Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber dressing. Wound Repair Regen. 2004;12(3): 288-294.

2. Surgical Site Infections. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. http://www.cdc.gov/ncidod/dhqp/dpac_ssi_data.html. Accessed November 17, 2008.

3. Gupta, SK, Lee S, Moseley LG. Postoperative wound blistering: is there a link with dressing usage? J Wound Care. 2002;11(7):271-273.

4. Vanscheidt W, Lazareth I, Routkovsky-Norval C. Safety evaluation of a new ionic silver dressing in the management of chronic ulcers. WOUNDS. 2003;15(11):371-378.

5. Klevens RM, Morrison M, Nadle J. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007;298(15):1763-1771.

AQUACEL, DuoDERM, Hydrofiber and Versiva are registered trademarks of ConvaTec Inc.

XC is a trademark of ConvaTec Inc.


Source: ConvaTec

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.